The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD
Crohn DiseaseThe purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.
Optoacoustic Detection of Inflammation Using MSOT Device
Graft Vs Host DiseaseColitis1 moreThe purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect inflammation in patients with chronic graft versus host disease of the skin or GI tract, Crohn's disease, or Colitis disease.
Prevention of Recurrent Clostridium Difficile Infection (CDI) in Patients With Inflammatory Bowel...
Inflammatory Bowel DiseasesUlcerative Colitis2 moreThe study will compare the effectiveness of Bezlotoxumab in individuals with active C. diff ( Clostridium difficile) infection who are diagnosed with Inflammatory Bowel Disease.
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological...
Crohn DiseaseWith this prospective, randomized, multicentre, parallel group pragmatic non-inferiority trial, the investigators will evaluate if endoscopy-driven introduction of biological therapy is not leading to more postoperative endoscopic recurrence at week 86 compared to systematic prophylactic biological therapy in patients with CD undergoing an ileocolonic resection with ileocolonic anastomosis. Secondary analyses will include influence on clinical, biological and surgical CD recurrence, serious adverse events, direct costs, work productivity, and quality of life. If the investigators can demonstrate the non-inferiority of an endoscopy-driven approach, this patient-tailored management could be advocated, while a more expensive systematic introduction of biological therapies could be limited. Finally, endoscopic images provided through the SOPRANO CD study, will be used to develop a new scoring system evaluating postoperative endoscopic recurrence.
Prospective Multicenter Randomized Comparative Study of the Treatment of de Novo Stenosis in Chron's...
Crohn DiseaseStenosis is one of the most frequent complications in patients with Crohn's disease (CD), causing greater morbidity and increasing the probability of repeated surgery and short bowel syndrome (1-3). Endoscopic balloon dilation (EBD) is clearly the treatment of choice for short stenoses located at the anastomosis of previous surgeries (4-6). However, there is no scientific evidence for determining the most appropriate treatment for de novo stenosis less than 10 cm in length (surgical versus endoscopic treatment), both in terms of efficacy and complications. Neither has it been established which of these two approaches has a greater impact on the quality of life of patients and on costs.
Reduce Crohn's-Associated Diarrhea With Sodium Channel Therapy
Crohn's DiseaseInflammatory Bowel DiseaseCrohn's disease is an inflammatory disorder that can affect any part of the gastrointestinal (GI) tract. Some patients still experience persistent diarrhea or other symptoms such as abdominal pain even when their Crohn's disease is in remission. Diarrhea and/or abdominal pain that is not responsive to standard therapies can significantly affect a patient's quality of life and ability to work. The purpose of this study is to test the safety and effectiveness of the drug ranolazine in reducing Crohn's disease-associated diarrhea and other symptoms. Ranolazine is approved by the US Food & Drug Administration (FDA) for chronic angina (a heart condition). This study is investigating if ranolazine could be used in the setting of Crohn's disease.
Synbiotics and Post-op Crohn's Disease
Crohn's DiseaseCrohn's disease (CD) is a lifelong incurable condition that causes inflammation of the intestinal tract of humans. The exact cause of CD is unknown, but genetics, diet, and the gut microbiome are all thought to play a major role. Many patients with CD will require surgery to remove affected portions of the gut, with ileocecal resections being the most common procedure performed. Regrettably, there is up to an 85% chance that disease returns to the surgical site. Strong immune suppressive medications may help to prevent disease relapse. However, patients are then at risk of serious side effects. Currently, no ideal post-op care exists for CD patients. This study aims to assess whether a post-op synbiotic therapy (i.e. probiotics plus dietary fiber) prevents disease relapse in participants with CD. To test this, participants will consume probiotics (strains of bifidobacteria) before their surgery and then probiotics plus fiber supplements after surgery. Probiotics are live bacteria that have been shown to reduce inflammation of the gut. Fiber is given after surgery to help promote beneficial bacterial taxa and prevent less favorable bacterial taxa from triggering CD relapse. Patients will take the supplements for 6 months following surgery. They will be seen monthly to assess the effects of treatment on quality of life, symptoms of disease recurrence, inflammatory markers, and the gut microbiome. All patients will also undergo a colonoscopy at the end of the study to check for endoscopic reoccurrence.
Proactive Infliximab Optimization Using a PK Dashboard Versus SOC in Patients With Crohn's Disease:...
Crohn DiseaseThe OPTIMIZE Trial compares whether iDose dashboard-driven infliximab dosing (iDose-driven dosing) is more effective and safer than standard infliximab dosing for inducing and maintaining disease remission in moderately to severely active CD.
Effect of the Exclusive Enteral Nutrition Combined With Azathioprine for Remission of Crohn's Diseases...
Crohn Diseasefor some patients with Crohn's diseases undergoing surgery,whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.
DWI MR-enterography Without or With Bowel Cleansing to Assess Intestinal Inflammatory Activity in...
Crohn DiseaseBowel Cleansing1 moreSince 2009, many studies tend to prove the effectiveness of diffusion-weighted MR-enterography in the assessment of inflammatory activity in IBD compared to standard MR-enterography, with the emergence of new radiological scores such as the Clermont score. Diffusion-weighted MRI (DWI) is a faster technique and does not require the injection of gadoline contrast medium, which is a desirable in view of recent data on their long-term adverse effects (intracerebral deposits, nephrogenic systemic fibrosis). The advent of 3T MRI, which provides a better signal, a better spatial resolution or the same examination quality in a shorter time, seems promising for the future of DWI. However, to date, there are still few studies carried out at 3T in this field or even few studies on the possibility of doing away with bowel cleansing, although this is one of the main demands of patients. All patients will undergo a simplified MR-enterography, which includes four sequences, without bowel cleansing or injection. On the same day, the standard MR-enterography will be performed as in clinical practice, after ingestion of the usual oral preparation. Three reading sessions of the examination will be organized at intervals of at least one month by two radiologists specialized in digestive imaging, blinded to the clinical and